Smoke evacuation system

ABSTRACT

An improved smoke evacuation system and method for removing gaseous byproducts of surgical procedures and noxious vapors from chemicals is provided. The smoke and vapor evacuation system includes a vacuum head positionable at a surgical site or incorporated into a workstation. The vacuum head includes a plenum, and a plenum support for preventing the plenum from collapsing when a vacuum or low pressure is established therein, and is adapted to facilitate the use of the system in a variety of surgical or commercial procedures at a variety of surgical sites or commercial workstations.

PRIORITY

The present application is a continuation of U.S. patent applicationSer. No. 09/710,288, filed Nov. 10, 2000, now U.S. Pat. No. 6,663,610,issued on Dec. 16, 2003, which is a Continuation-In-Part of U.S. patentapplication Ser. No. 09/673,406, filed Mar. 29, 2002, now U.S. Pat. No.6,942,650, issued on Sep. 13, 2005, which is a 35 USC 371 applicationbased on International Application No. PCT/US99/08207 filed Apr. 15,1999, which claims the priority of U.S. Provisional Patent ApplicationNo. 60/082,125, filed Apr. 17, 1998.

BACKGROUND

This invention relates to equipment, systems and methods for the removalof gaseous and/or substantially gaseous material. Such materialincludes, but is not limited to aerosol and particle byproducts ofsurgical procedures and any procedures involving cutting, heating orburning, such as odors from chemicals, ultrasonic vapors, and ion dustparticles. More particularly, the present invention relates to anevacuator or vacuum head for an evacuation system that efficientlyremoves smoke, vapor, or plumes released by chemicals or produced by theuse of lasers, sonic cutting and/or cautery or other surgical techniquesor instruments at a surgical site.

Heating and/or burning of tissue during surgical procedures has becomecommonplace. An unwanted byproduct of such heating and/or burning,however, is the smoke generated thereby. Smoke plumes can obscure thesurgeon's field of vision and the odor generated is unpleasant anddistracting to the entire surgical team and to the patient, if awake.Moreover, the smoke plume may contain infectious agents that present adanger to persons in the operating room, and which can leave a lingeringcontamination within the operating area. Chemical vapor (e.g., such asthat produced by the cleaning of computer parts) is, likewise,irritating to the respiratory tract of those who inhale it and may becarcinogenic.

Smoke evacuation and filtering systems have been developed to removesmoke plumes from surgical sites and chemical vapors from the workenvironment. Such systems typically include a hose connected to a vacuumsource or generator and a suction wand connected to the hose, that is,placed at the site where the aerosol is generated. Various filtrationsystems have been used in conjunction with such vacuum generators toremove odor and infectious agents. Typically, the wand and hoses ofknown evacuation and filtration systems have required the constantattention or activity of an attendant to hold the wand or the nozzle ofthe hose close to the surgical site. Another problem is that the flow ofair through the hose nozzle and the suction motor are sources ofexcessive and unwanted noise in the operating room or at theworkstation.

More recently, at least in part to address the problems with wands,smoke evacuation systems may include an end effector that can be held inplace at a surgical site without the constant attention of a nurse orother attendant. At least one such evacuation system and end effector isdisclosed in U.S. Pat. No. 4,921,492 (Schultz et al.), the disclosure ofwhich patent is incorporated herein by reference. Schultz et al.disclose an end effector for removing the gaseous byproducts of lasersurgery from a surgical site. The end effector includes a flexible hoseand a pliable vacuum head adhesively attachable in a substantiallyairtight relationship around a surgical site. The vacuum head includes agenerally annular plenum for drawing plumes away from the surgical sitefrom around a 360° arc. A porous plenum support prevents the flexibleplenum from collapsing in the presence of a vacuum, and diffuses thevacuum around the entire periphery of the plenum.

U.S. Pat. No. 5,015,243 (Schifano) discloses another smoke evacuatorincluding a flexible suction head for surrounding an operative site todraw smoke and air from around a perimeter of the site as smoke isproduced. In one embodiment, the suction head is a doughnut shapedtubular member including a plurality of radial openings on an interiorsurface of the tubular member that faces the operative site. Schifanoteaches that the tubular ring member may be circular or oval, and thatit need not completely surround the operative site as long as air isdrawn substantially in a surrounding fashion.

Another problem faced during operations is surgical site infection.Surgical site infections account for a large number of nosocomialinfections. These types of infections occur when bacteria from theoperating area enters a surgical site. Surgical site infections canincrease the probability of death, and can increase a patient's hospitalstay and cost. An article entitled “Guideline For Prevention of SurgicalSite Infection, 1999”, published in the American Journal of InfectionControl, May 1999, pp.97–118 (Mangram, Alicia J. et al.), the disclosureof which article is incorporated herein by reference, presentsrecommendations for preventing these types of infections. The articlesuggests that one way to control surgical site infections is to improveoperating room ventilation. The article discloses that a laminarairflow, designed to move particle-free air (which may be known as“ultraclean air” or like) over the aseptic operating site at a velocityof around 0.3–0.5 mm/second, effectively sweeps particles out of itspath, and reduces surgical site infections following operations by morethan 50%. Combining the laminar airflow of ultra-clean air over asurgical site with a smoke evacuation system could increase the safetyand comfort for the operating room staff and the patient.

While smoke evacuation systems and end effectors of the Schultz et al.and Schifano type are well-suited for their intended purposes, there isroom for improvement. For example, while the end effectors are pliableor flexible to conform to a surface to which they are attached, neitherdiscloses a skeletal stiffening structure or frame for helping tomaintain a conformed shape. Such a skeleton or frame would be valuableto adapt end effectors or vacuum heads for smoke evacuation for use onor near irregular physical features such as, for example, the ear, nose,mouth, or in the area of joints. It would also be advantageous if thegenerally central, site access opening of such end effectors could beselectively varied in size to accommodate different sizes of incisionsand different procedures, and if end effectors could be made availablewith the intake opening or openings in various locations, so that aparticular end effector could be selected depending on the procedure tobe performed. It would be advantageous if end effectors were availablein a generally elongated, tubular shape bendable into a selectedconfiguration by the user, and wherein the shaped or bent effectorswould tend to remain in the selected configuration. It would beadvantageous if a blower station and vacuum station could be set up andconnected to an end effector in order to create and/or supply andevacuate a laminar airflow of ultra-clean air across a surgical site,and/or to do so in conjunction with filtration. It would also beadvantageous if an end effector or vacuum head could be integrated withthe widely used customary surgical drapes or drape material, orincorporated into part of a workstation that would contain noxiouschemical fumes.

SUMMARY

The present invention provides an evacuator well-suited for removing orevacuating smoke, chemical vapors, aerosols, gaseous or generallygaseous material and fluids, including fluids with entrained particlesor other material. It is well-suited for use in removing such substancesfrom surgical sites, workstations and manufacturing assemblies orprocessing sites.

The needs outlined above are in large measure solved by a smokeevacuation system and method, including an evacuator, in accordance withthe present invention. The embodiments described herein are designed toefficiently and quietly remove smoke or other aerosols, including smokeor bioaerosols generated during surgical procedures, and can be used ata surgical site without constant attention or manipulation by thesurgeon or an attendant. They would also remove vapor from the worksite.

An improved smoke evacuation system and method for removing gaseousbyproducts of surgical or commercial procedures is provided by thepresent invention. The smoke evacuation system includes a vacuum headpositionable at a surgical or other work site. The vacuum head includesa plenum, and a plenum support for preventing the plenum from collapsingwhen a vacuum or low pressure is established therein, and is adapted tofacilitate the use of the system in a variety of surgical procedures ata variety of surgical sites.

In one embodiment, the present invention comprises a vacuum smokeevacuator head for coupling to a vacuum source for withdrawing generallygaseous byproducts, including smoke, fine particulate matter, air andthe like, from a surgical or commercial site. The smoke evacuator headis substantially made of a generally pliable or flexible material anddefines a plenum. A plenum support is carried within the plenum toprovide support to the plenum and to prevent the plenum from collapsingwhen a vacuum or relatively low pressure area is established therein.The smoke evacuator head includes an open intake facing and/or intakeopenings, and may be positioned adjacent to or in a surgical site. Anadhesive may be carried by the head for maintaining it in a selectedposition or location relative to the surgical site.

In one embodiment, the smoke evacuator head includes at least one accessopening which may be selectively expanded in size. Typically, the accessopening may be generally centrally located in the vacuum head, and hasan initial peripheral edge which may be moved generally concentricallyoutwardly by selectively removing one or more removable, generallyconcentric peripheral portions extending substantially around theopening. Also typically, the opening, whether the initial size or one ofthe expanded sizes, may be covered or sealed before use by a removablefilm.

In another embodiment, the smoke evacuator vacuum head includes askeletal stiffening member or positioning frame whereby the head may beconfigured and tends to remain in the selected configuration. Theskeletal structure may comprise a single, flexible elongated memberformed of a suitable material which may be bent or twisted, yet hassufficient rigidity to retain the selected bend or twist. The skeletalstructure may be internal or external, and may comprise a single,elongated member, a single annular member, a plurality of axiallyaligned members, a number of parallel and/or branch members or acombination thereof. This embodiment may be well-suited for use inregions of the body having rather irregular surfaces such as joints, theear, nose or mouth.

In another embodiment, the smoke evacuator may comprise a generallytubular body having two ends, one of which is adapted to be connected toanother smoke evacuator vacuum head or to a coupling, such as a hose,for operably coupling the tubular body to a vacuum source. The other endmay be free. The body may have one or more regions comprising openingsor an open facing for admitting smoke and the like when a vacuum or lowpressure is established in the body. In this embodiment, the body mayhave a stiffening element or a skeletal structure to allow the body toeasily bend and remain in a particular shape for use in differentsituations. This embodiment of the vacuum head may be well-suited foruse, as an adjunct or alone, in deep incisions or wounds during surgicalprocedures.

In yet another embodiment, the smoke evacuator vacuum head forms aplenum including a substantially open facing portion for beingpositioned generally adjacent to a smoke or aersol producing site. Inone embodiment, wherein the plenum has a top, outwardly facing wall, isgenerally annular and includes a generally central access opening, theperiphery of the opening being formed by an inner wall, the open facingmay be formed in and/or adjacent to the inner wall comprising, forexample, a bevel and/or a portion of the top wall. This embodiment iswell-suited for use in surgical procedures during which a flap or ridgeof skin or tissue may be formed, for example, around or as a result ofthe incision. Such procedures include plastic surgery procedures andmastectomies, for example, where the vacuum induced in the plenum maytend to pull skin flaps or tissue into it, particularly when the skinflap or tissue is held straight up.

In another embodiment, the evacuation system of the present inventioncomprises an evacuation hose for detachably connecting a vacuumgenerator or source and a vacuum head that generally surrounds asurgical site. The vacuum head is substantially made of a generallypliable or flexible material and defines a plenum having a generallycentral opening. A porous plenum supporting material is carried withinthe plenum to provide a degree of rigidity to the plenum and to preventthe plenum from collapsing when a vacuum or relatively low pressure areais established therein. The plenum includes an open facing regionadjacent to the central opening. An adhesive may be carried by the skincontacting wall of the vacuum head for maintaining the vacuum head inplace at a surgical site.

An embodiment and feature of the present invention is the concept of afoam supported channel of selectable cross-sectional area incorporatedor integrated with a surgical drape, wherein the channel may be used toconvey smoke and/or other aerosol debris away from a surgical site.

Any of the embodiments of the smoke evacuation system or vacuum headdescribed herein may be provided in sterile form and in a coloracceptable in an operating room environment.

In one embodiment, the smoke evacuation system of the present inventioncomprises a vacuum head end effector including generally contiguous,concentric areas or regions, which may be oval, formed or separated bygenerally concentric perforations whereby the areas may be selectivelyremoved to correspond with required length of an incision or proceduralarea.

In one embodiment, the end effector in accordance with the presentinvention would have a pre-provided generally central and oval cutout ofspecific predetermined dimensions, the purpose of which would be to forma primary or initial work area, and to more easily allow the surgeon orattendant to remove surrounding peripheral oval sections to expand theoriginal opening.

In one embodiment, each removable section of the vacuum head may beprovided with a paper backed adhesive running on one surface of thesections. The paper backing would be removed once the size of the fieldor work area is determined, thereby allowing the remaining portion ofthe vacuum head and/or drape to affix to the patient's prepped skin orto the medical drape covering the intended site of the surgery.

In one embodiment, the end effector would have suitable connectors,nozzle adapters, and/or connection features, e.g., to allow forsimultaneous coupling to both a source of selected fluid or gas, e.g.,ultra-clean air, and a source of low pressure or vacuum. In thisembodiment, the end effector would provide a unidirectional, laminarairflow over the work site. The end effector includes a plenum having acentral opening, a plenum support for preventing the plenum fromcollapsing when an airflow or a vacuum or low pressure is establishedtherein, and is adapted to facilitate the delivery of, e.g., ultra-cleanair across the generally central opening of the head.

In some embodiments, one or more manifold-like connection handles ortubes would extend from the foam filled channel or vacuum head todeliver an airflow and/or to convey the smoke and vapor mixture from theoperative site into a conduit and then to a collection, filtrationand/or deodorization device wherein the mixture may be processed and theair may be returned to the room.

In some embodiments, the skin of the drape may cover the end effector,the manifold and the drape in continuity. In these and otherembodiments, the manifold(s) may be provided to include either straight,i.e., parallel, and/or curved extension lips or walls that extend intoor on either side of the plenum support that supports the outer walls ofthe plenum or evacuator vacuum head. The purpose of these lips or wallswould be to prevent the possible kinking, narrowing or other form ofocclusion by the covering skin of the drape at the plenum support/manifold interface or junction. This occlusion might be caused by thedownward force placed on the manifold by the attached tubing thatusually trails or falls to the floor of the operating room. In someinstances, when suction or reduced pressure is applied without the lipextensions in place, the skin can invaginate and cover the entranceorifice of the manifold.

Another embodiment includes a chamber or gathering site for theevacuated smoke as it leaves the foam-filled channel or the plenumtoward the exit site of the manifold or connection nozzle. The chamberis attached to the lip extensions or walls (described in the previousparagraph) at one end and forms or is attached to an exit port at theother end. The chamber and/or exit port may be adapted to increase flowvelocities by including an area of decreased cross-sectional area. Theexit port from which the smoke mixture leaves the smoke evacuator may becoupled to a typical conduit or hose.

Any of the embodiments disclosed herein may be formed by a wall or skinwhich may be made of the same as the material of a surgical drape. Theskin may or may not be fire retardant or resistant, and any of theembodiments may be preferably composed of bio-compatible material and becapable of disposition as such materials are typically disposed of.

It should be appreciated that features of any of the embodiments of thepresent invention may be selectively combined to adapt the smokeevacuator vacuum head for a variety of situations and surgicalprocedures.

Other features and advantages of the smoke evacuation device and methodof the present invention will become more fully apparent and understoodwith reference to the following description and appended drawings andclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a fragmentary, perspective view of a smoke evacuation systemincluding an vacuum head end effector;

FIG. 2 is a front elevational view of the end effector shown in FIG. 1,with parts broken away for clarity;

FIG. 3 is a top perspective view of an embodiment of the end effectorvacuum head in accordance with the present invention;

FIG. 4 is a side elevational view of the end effector vacuum headdepicted in FIG. 3;

FIG. 5 is an exploded perspective view of another embodiment of thepresent invention;

FIG. 6 is a perspective view of the embodiment depicted in FIG. 5;

FIG. 7 is a perspective view of another embodiment of the presentinvention;

FIG. 8 is a fragmentary perspective view of another embodiment of thepresent invention;

FIG. 9 a is a fragmentary perspective view of another embodiment of thepresent invention;

FIG. 9 b is a fragmentary perspective view of another embodiment of thepresent invention;

FIG. 10 is a fragmentary perspective view of another embodiment of thepresent invention;

FIG. 11 is a perspective view of another embodiment of the presentinvention;

FIG. 12 is a perspective view of another embodiment of the presentinvention;

FIG. 13 is a perspective view of another embodiment of the presentinvention;

FIG. 14 is a perspective view of another embodiment of the presentinvention;

FIG. 15 is a perspective view of two embodiments of the presentinvention as they might be used in conjunction;

FIG. 16 is a perspective view of another embodiment of the presentinvention;

FIG. 17 is a perspective view of another embodiment of the presentinvention;

FIG. 18 is a perspective view of another embodiment of the presentinvention;

FIG. 19 a is a perspective view of another embodiment of the presentinvention;

FIG. 19 b is a perspective view of another embodiment of the presentinvention;

FIG. 19 c is a side view of another embodiment of the present invention;

FIG. 19 d is a perspective view of another embodiment of the presentinvention

FIG. 19 e is a perspective view of another embodiment of the presentinvention;

FIG. 19 f is a top view of another embodiment of the present inventionwith the top material of the plenum removed;

FIG. 19 g is a perspective view of the embodiment of the presentinvention shown in FIG. 19 f; and

FIG. 20 is a perspective view of an embodiment of the invention in usein a workstation.

DETAILED DESCRIPTION

The accompanying Figures and this description depict and describeembodiments of the smoke evacuation system and method of the presentinvention, including the smoke evacuator vacuum head, and features andcomponents thereof. As used herein, the terms “evacuator”, “smokeevacuator”, “end effector”, “vacuum head” and like terms are intended toencompass a structure or structures into which gaseous or generallygaseous or particulate material, such as aerosols, smoke or vapor, maybe introduced or be drawn from when the structure is operably coupled toa source of low pressure or vacuum. Such a structure or structures maybe placed generally adjacent to a site producing a gaseous or generallygaseous material. As used herein the term surgical field is intended toencompass places where an incision is to be made in the skin or whereother surgical operations or procedures are performed or to beperformed. With regard to fastening, mounting, attaching or connectingthe components of the present invention to form the device and system asa whole, unless specifically described otherwise, such are intended toencompass conventional fasteners such as machine screws, nut and boltconnectors, machine threaded connectors, snap rings, hose clamps such asscrew clamps and the like, rivets, nuts and bolts, toggles, pins and thelike. Components may also be connected by adhesives, glues, heatsealing, snap fitting, welding, ultrasonic welding, and friction fittingor deformation, if appropriate. Unless specifically otherwise disclosedor taught, materials for making components of the present invention maybe selected from appropriate materials such as metal, metallic alloys,natural and manmade fibers, vinyls, plastics and the like, andappropriate manufacturing or production methods including casting,extruding, molding and machining may be used.

Any references to front and back, right and left, top and bottom andupper and lower are intended for convenience of description, not tolimit the present invention or its components to any one positional orspacial orientation.

Referring to FIGS. 1 and 2, a smoke evacuation system 10 in accordancewith the above-noted Schultz et al. patent is depicted. The systemincludes an end effector 12 detachably connected to a suitable vacuumgenerator and filtration assembly 14. In one embodiment, the endeffector 12 may include a flexible hose 16 coupled to a vacuum head 18by a generally tubular manifold-like handle 20. In one embodiment, thevacuum head 18 includes a generally flat body 22 having a top wall 24,bottom wall 26 and outer sidewall 27 extending between the top wall 24and bottom wall 26. The body 22 is preferably formed from a nonporous,pliable synthetic resin so that it will conform to the surfacesurrounding the surgical site. The top, bottom, and side walls 24, 26,27 together substantially define a generally annular, internal plenum28. The walls form an outer skin of the plenum 28 and may be composed ofa medical grade, pliable, substantially non-porous material. Thematerial of choice may be a synthetic, or it may be a natural material,such as fibrous material, e.g., cellulose or cotton fiber basedmaterial, such as presently used in surgical drapes and/or towels. Thematerial of choice may be with or without flame-retardantcharacteristics. Preferred synthetic materials may be selected fromopen-celled foams, urethane film, spun lace polyester, nonwovenpolyurethane tape and the like.

The top wall 24 includes an access aperture 32, and the bottom wall 26includes an access aperture 34, typically, but not necessarily, alignedand/or substantially congruent with the top wall access aperture 32.Preferably, a layer or adhesive 36 is carried by the top wall 24, and aclear film 38 is removably carried in place over the top access aperture32 by the adhesive 36. Preferably, the bottom wall 26 includes a firstadhesive layer 40 and a clear film 42 removably carried by the firstadhesive layer 40. A second adhesive layer 44, which may have anantiseptic embedded therein, is carried by the bottom wall clear film42. A sterile, peel-off shield 46 is removably carried by the antisepticadhesive layer 44.

It will be appreciated that, upon application of a vacuum to the body22, the top and bottom wall 24, 26 would be urged together, therebyreducing the volume of the plenum 28. Therefore, in the end effector 18depicted in FIGS. 1 and 2, and in the embodiments of the inventiondescribed herein, an inner core plenum support 48 formed from a porousmaterial such as foam urethane, or another appropriate reticulated,open-cell foam material, a supporting matrix, or the like, may becarried within plenum 28, to provide the body 22 with some rigiditywithout substantially detracting from the flexibility of the vacuum head18. The inner core 48 comprises an inner plenum supporting structure 48that permits the flow of air and smoke into the plenum 28 while blockingthe ingress of larger materials such as tissue or surgical materials.Preferably, the inner core support 48 should be made of a synthetic ornatural material that is hydrophobic so that it will resist absorptionof fluids often present in the operative field. A reticulated open cellfoam of a size between 5 and 25 pores per inch (ppi) is well-suited forthe inner core. In another embodiment, the plenum support core 48 may bemolded and/or may be formed contiguously with the outer skin, and may beprovided with a plurality or matrix of airflow shafts or channels.

Whether the shape of vacuum head 18 is generally circular, generallyoval or a different shape, in some embodiments, it will be noted thatthe plenum 28 provides for evacuation of generally gaseous materialsubstantially around a complete 360° arc.

FIGS. 3 and 4 depict an embodiment of the smoke evacuator 18 of thepresent invention, wherein the central access aperture 32 is expandableto form a larger size aperture or opening 50 by removing a peripheralportion 52 of the evacuator vacuum head 18 from around the originallyprovided access aperture 32. The top and bottom walls 24, 26 and theplenum support material 48 may include a line of weakness 56, be scored,cut or partially cut to define the removable portion 52 and tofacilitate its removal. A selected number of generally concentric orshaped removable portions may be provided. The line of weakness,scoring, cut or perforations 56 may be substantially concentric andcongruent with respect to the initial access aperture 32, or they may beadapted to expand the initial access aperture in a selected direction orinto a selected shape, e.g., they may comprise one or more arcs or linesof weakness beginning and ending at the peripheral edge of the accessopening (see, for example, lines of weakness a and b shown in FIG. 6).(In describing this and other embodiments, features in common with theend effector depicted in FIGS. 1 and 2, and with other embodiments ofthe invention, are and will be commonly referenced.)

FIGS. 5, 6 and 12 depict another embodiment of the smoke evacuatorvacuum head 18 of the present invention, wherein the vacuum head 18 isprovided with a variable size access aperture, and is integrated with asurgical drape 60 comprising a relatively large, flexible, generallycloth-like sheet material. Such a drape or drapes are widely used toestablish or set off a surgical field, may or may not be generallytransparent, and may be formed by a polypropylene material or the like,such as PVC or combinations of polypropylene and cellulose. They maycarry an adhesive on one surface for connection to the skin of apatient, typically, four strips of adhesive to define a periphery. Onesurface of the drape may have an adhesive thereon for attachment to thevacuum head end effector 18. Integration of the vacuum head end effector18 of the present invention may be accomplished by providing a drape orpiece of drape material with an opening, placing the end effector 18over the opening, and attaching or sealing the edges of the end effector18 to the drape (see FIG. 6). The bottom wall of the end effector 18 maybe omitted, in which case the top or outside side wall 24 may be joinedto the drape, whereby the drape forms the bottom wall, completing theplenum 28 and encompassing the open-cell, reticulated foam forming theplenum support 48. In use, the integrated drape and end effector 18 maybe placed over an intended incision site with the access opening alignedwith the site. A tab 64 may be grasped and pulled to permit access tothe site. If a larger incision site opening is required initially, or ifthe incision site needs to be expanded or extended, another tab 66 maybe grasped and pulled to remove a peripheral portion 52, therebyenlarging, specifically lengthening, the opening. As depicted in FIG.12, the pre-cut access opening covering is provided with as many tabs asconvenient to facilitate grasping and pulling the covering away from theend effector 18. Pulling one of the tabs releases the pre-perforatedcovering skin and allows the pre-cut foam 48 to be removed.

FIG. 7 (and others, including FIGS. 13–16) depict another embodiment ofthe present invention wherein a wire-like skeletal member 70 isprovided. The skeletal member 70 is flexible and bendable to the degreethat it may be manipulated, bent or twisted into a desired shape, yet itis inflexible or rigid enough to retain its bent or twisted shape. Itmay be located in the plenum 28 as shown, or it could be appropriatelysecured to the exterior of the end effector 18.

FIG. 7, and FIGS. 8–10, depict embodiments of the present inventionwherein the walls of the plenum 28 defining the access opening oraperture is an open facing 74, and wherein the open facing 74 extendsinto the top wall 24 of the plenum 28. As shown in FIGS. 7 and 8, theaccess opening wall is substantially completely an open facing 74 whichextends upwardly at an angle or bevel 76 into the top wall. The bias orangle into the top wall may be from 10 to 60 degrees, with 45 degreeswell-suited for many procedures. FIGS. 9 a and 9 b depict two unbeveledembodiments, and FIG. 10 depicts an embodiment wherein the inside wallof the plenum 28 is substantially continuous, only the bevel 76comprising the open facing portion of the plenum 28. These embodimentsgenerally are well-suited for use in surgical procedures involving aflap or ridge of tissue which, if the top wall or a portion thereof wasnot adapted to provide an intake for gaseous material, might occlude theopen facing, blocking or at least interfering with the flow of thegaseous material into the plenum 28. The embodiment depicted in FIG. 10may be further adapted for particular surgical procedures, such asprocedures involving the breast, by providing a sealing means, such asan adhesive, on the inside rim or wall 29 of the plenum 28 so it can beadhered or sealed in place to the breast with a portion of the breastextending through the access opening.

FIG. 11 depicts a drape/smoke evacuator embodiment of the presentinvention wherein dual vacuum coupling attachment handles are provided.Such an embodiment may be well-suited for procedures requiring largeincisions, such as spinal procedures, thoracotomy, large abdominalincisions and the like. In one embodiment, the evacuator embodiment ofFIG. 11 may be used as a stand alone device without a drape as depictedin FIG. 11.

FIGS. 13 and 14 depict another embodiment of the smoke evacuator of thepresent invention wherein the plenum 28 is formed by a substantiallycontinuous wall, which may be a single piece of extruded material orwhich may be formed from joined top, bottom and side walls. In thisembodiment, the vacuum head 18 and the plenum 28 have a generallytubular, straight, elongated shape with two free ends, one end 80 ofwhich may be closed and the other end 82 which may be adapted to becoupled to another embodiment of the end effector 18 of the invention,as shown in FIG. 14. The end 82 adapted to be coupled is provided with asharpened, cannula-like member 84 for penetrating the wall of the plenum28 as shown in FIG. 14. The end 82 may be flattened or otherwise adaptedto be similarly attached to suction tubing or to the above describedchannel. In one embodiment (not shown), the cannula-like member 84 isnot sharpened as depicted in FIG. 13. In other embodiments (not shown),this embodiment of the invention may be adapted for direct coupling to ahose or other fitting, or may include or be attached to a manifold orhandle 20 generally similar to that shown in FIG. 1, for coupling to ahose or other fitting. Note that FIG. 14 also depicts that thestiffening skeletal member 70, shown in two of its possible locations,may be used to configure and position the generally tubular smokeevacuator 18 embodiment, or a portion thereof, in a relatively deepincision or wound.

FIG. 15 depicts an embodiment of the smoke evacuator of the presentinvention adapted for spinal operations or other procedures wherein arelatively long incision may be used. The plenum 28 is formed in theshape of two generally parallel tubular members 88, 90, each havingsubstantially continuous top, bottom, outside and end walls, and aninside wall comprising an open facing 74. Each embodiment of theinvention may include a generally enlarged internal plenum spaceadjacent to the manifold port or handle 20. In the evacuator of FIG. 15,for example, the top wall 24 and bottom wall 26 are extended to form anenlarged plenum space 100 adjacent the manifold port or handle 20, suchthat the suction force generated at the manifold or handle 20 is moreevenly dispersed, including throughout the plenum and along the openfacing 74. Such a feature may be included in any of the embodiments ofthe invention described herein. Note that, as in all the embodimentsdescribed herein, the malleable, skeletal stiffening member 70, whichmight be formed of nitinol or similar “memory” material, may beincorporated to facilitate re configuring this embodiment to, forexample, the configuration shown in phantom. This embodiment of thevacuum head 18 may have a single connection manifold or nozzle 20 asshown, or it may be adapted to have two manifolds with a circuit adapterto permit them both flow into a single ⅞″ vacuum hose (see, for example,FIG. 11). Such circuit adapters are readily available as standardcatalog items for respiratory therapy and anaesthesia.

FIG. 16 depicts an embodiment of the smoke evacuator 18 well-suited foruse in dental surgery, e.g., a “bite-block” embodiment. It should beappreciated that the smoke evacuator 18 maybe provided in anyconfiguration suitable for use in or around the mouth, and thatsubstantially the entire skin or walls forming this embodiment wouldpreferably be non-absorbent.

FIGS. 17 and 18 depict an embodiment wherein a generally tubular vacuumhead 18 comprises an internal plenum region adjacent to the manifoldport or handle 20 and two plenum arms 90, 92. The two plenum arms 90,92, which, as in FIGS. 17 and 18, may be two free arms, may be curled orcurved to substantially surround a surgical site. An advantage of thisembodiment is that the plenum arms 90, 92 with their free end areflexible, whereby the head 18 is made more flexible so it may moreeasily assume and conform to the shape of the underlying tissue. Thearms 90, 92, and thus the head 18, may move in various directionsaccording to the layout of adjacent tissues. Because, in one embodiment,one surface of the vacuum head 18 of FIGS. 17 and 18 may have anadhesive attached thereto for attachment to a drape, it may be desirableto have one embodiment wherein the ends 90, 92 face one direction whenviewed from the top and another embodiment wherein the ends 90, 92 facethe other direction. These embodiments may provide for the flexibilityneeded for various surgical procedures, including procedures onbilateral, mirror image structures or tissues.

FIGS. 19 a–g depict embodiments of the smoke evacuator 18 which can beused for creating unidirectional and/or laminar flow of ultra-clean airor other gas or fluid through or over a work site. These embodiments ofthe present invention provide a laminar or balanced airflow andevacuation and/or filtration system. In these embodiments, the inflowrate of ultra-clean air or other gas may be at a steady rate, a variablerate, or pulsed.

In one embodiment, as shown in FIG. 19 a, the evacuator 18 comprises aplenum 28 having a central opening 32, a plenum support 74 forpreventing the plenum from collapsing or expanding when a flow, highpressure, vacuum, or low pressure is established therein, and is adaptedto facilitate the delivery of a fluid, e.g., ultra-clean air, across orin the central opening 32 of the evacuator 18. In one embodiment, theevacuator 18 employs two coupling attachment handles 20 and 116. One ofthe attachment handles 20, acting as an outlet, could be attached to alow pressure, or vacuum source. The other attachment handle 116, actingas an inlet, could be attached or hooked up to a source of ultra-cleanair or other gas, including a high pressure source.

The ultra-clean air could be blown under pressure into the evacuator 18through the attachment handle 116 as shown by arrow 118. The inflow ofultra-clean air or other gas, may be at a steady rate, a variable rate,or a pulsed rate. In an embodiment where ultra-clean air flows in at asteady rate, the plenum support 74 could act to evenly distribute theair so that a generally uniform, unidirectional laminar flow of the airwould flow through the aperture 32 and over the surgical work site asshown by arrows 122. The vacuum source, pulling air through theattachment handle 20 could act to pull the ultra-clean air through theevacuator 18, and into a filter, as shown by arrow 120. In someembodiments, particularly those in which the central opening 32 issmall, the pressurized source of ultra-clean air may be sufficient tocreate a substantially laminar flow of ultra-clean air in the centralopening 32, and into a suitable passive exhaust system, including apassive filtration system, such as that described in U.S. Pat. No.6,110,259, the disclosure of which is incorporated herein by reference.In other embodiments, a “pull” could be used to establish an airflow,i.e., a vacuum source could draw air into and through the centralopening 32. In other embodiments, a “push/pull” arrangement could beused, wherein a fluid, e.g., ultra-clean air or a mixture of ultra-cleanair and another gas or fluid, would be supplied through the inlet 116 bypressure, and withdrawn through the outlet 20 by a vacuum. In theseembodiments, it is preferable that the outflow is greater than or equalto, the inflow. This helps the invention to act as an effectiveevacuation device by preventing a buildup of the inflow fluid in thecentral opening 32. In any embodiment, suitable pre or post plenumfilters may be used. In other embodiments, other types of gases may beblown through the plenum 28, such as an inert gas, or oxygen, dependingon what the situation requires.

The present embodiment could be self contained or incorporated into asurgical drape. The present embodiment could also have a centralaperture 32 of various shapes and sizes, limited only by the requirementof having a sufficiently high air pressure and/or low air pressure tomaintain a controlled, unidirectional airflow velocity completely acrossthe opening 32. The coupling attachment handles 20, 116 could couple tothe air pressure sources via standard surgical tubing or other flexibleforms of tubing.

An advantage of these embodiments is that a laminar airflow ofultra-clean air has been shown to act as an additional measure againstsurgical site infection risk for certain procedures. The embodiment isdesigned to move particle-free air (called ultra-clean air) over theaseptic operating field at a uniform velocity. The laminar airflow mayact as a barrier to and may sweep away contaminants, e.g., bacteria, andparticles in its path, and those particles could then be sucked into afilter via the vacuum source.

FIG. 19 b shows an alternative embodiment of FIG. 19 a, where multipleinlet and outlets are available for a ultra-clean air source and avacuum source. In this embodiment, two attachment handles 116, 116′ areprovided on one side for coupling to a fluid source, e.g., ultracleanair, and two attachment handles 20, 20′ are provided on the other sideof the plenum for coupling to a vacuum. This type of head could beuseful in situations where the surgical site is quite large, like alarge incision on the back. This embodiment would also be well suitedfor using a mixture of two different fluids to flow to the plenum. Theattachment handles 116, 116′ could be adapted to separately couple toeach fluid source.

Other variations of the invention shown in FIGS. 19 a and b arepossible, such as more attachment handles on one side than the other, orone side of the plenum could be thicker than the other as shown in FIG.19 c. In FIG. 19 c, one side of the top of the plenum 24′ is at a higherlevel than the other side of the top of the plenum 24″. In thisvariation, the pathways from the inlets and outlets into or out of thecentral opening may be manipulated in order to create a desired fluidflow profile. One possible passageway 45 is shown in phantom in FIG. 19c creating a fluid flow profile 47. This could create a betterdistribution of the airflow, either out of the fluid source, or into thevacuum.

In another variation of FIGS. 19 a and 19 b, there could be more thanone central opening, as shown in FIG. 19 d. In another variation, theplenum 28 may have a different shape in order to better conform with itswork area and/or to shape the airflow.

One embodiment of the present invention, as shown in FIG. 19 e, couldinclude manifolds 130 to preferentially direct the airflow to a specificportion of the central aperture 32. The manifolds 130 can be constructedto join the top and the bottom of the plenum, and may be solid orperforated. The manifolds 130 can act to prevent the airflow fromdiffusing in all directions as it enters from the inlet 116, by helpingto concentrate and direct the flow through the central aperture 32,towards the outlet 20. In one embodiment, the preferential direction ofthe airflow out of the inlet 116 and into the central aperture 32subtends or transverses an arc of approximately 5°, but is less thanapproximately 180°. In another embodiment, the manifolds 130 can act todirect the airflow so that the airflow covers at the most, the centralhalf of the skin surface area exposed in the central aperture 32. Anadvantage of the manifolds 130 is that they help to direct the airflowmore directly and evenly over the surgical site. Without the manifolds130, a portion of the airflow may diffuse into and through the plenumsupport 74, effectively flowing around the surgical site. Also, atcertain times, objects will be in the central aperture 32, such as asurgeon's hand, or an instrument when making a retraction. Withoutmanifolds, the airflow will take a path of least resistance, which maybe into the plenum support 74 and around the central aperture 32. Inthese situations, manifolds 130 will force the airflow to the centralaperture 32, so that the airflow can still effectively sweep awayparticles or plumes.

In another embodiment, as shown if FIGS. 19 f and 19 g, baffles 140 canbe used to have a plenum in which the laminar flow of air is balancedacross the central opening 32. FIG. 19 f shows the embodiment from a topview with the top part of the plenum removed in order to see the innerconstruction. In this embodiment, one or more baffles 140 can be set inthe plenum support area between the inlet port 116 and the centralaperture 32 the baffles 140 can help to separate and direct the airflowinto lanes or channels so that a consistent air velocity is achievedacross the entire edge 142 of the central aperture 32. In thisembodiment, the input 116 and output 20 ports can have varying sizes inorder to help achieve a balanced airflow across the central aperture 32.FIG. 19 g shows a perspective view of the embodiment described above asit could be used.

In use, it should be understood that operation of all the embodimentsdisclosed herein may be generally similar. The vacuum head 18, or thedrape 60 with the vacuum head 18 integrated, is detachably affixed tothe skin surrounding a surgical site by peeling off the sterile peel-offshield 46 and pressing the adhesive layer 44 carried by the bottom wall26 of the body 22 against the skin. It will be appreciated that theflexible vacuum head 18 permits a complete, airtight seal of the bottomwall 26 against the skin or any skin covering (such as a clear drape).The films 28, 42 carried by the top and bottom walls 24, 26,respectively, can be entirely removed. Upon actuation of the vacuumsource 14, air is drawn into the plenum 28, and is transported throughthe flexible hose 16 and into the filter (not shown) in the vacuumsource 14. The porous plenum support 48 carried within plenum 28prevents plenum 28 from collapsing under the influence of the vacuum.The plenum support 48 also may be adapted to enhance the effect ofdiffusing the vacuum around or through the plenum 28, thereby enhancingthe drawing air into the plenum 28 around its entire periphery or openfacing, rather than solely in the vicinity of handle 20. Moreover,drawing air through the larger opening presented by the plenum 28reduces the noise created by the flow of air into hose 16. Gaseous oraerosol material produced at the surgical site is thereby drawn into theplenum 28 and evacuated through flexible hose 16. The plenum support 48,due to its porous nature, also may act as a filter as the smoke is drawnthrough it, and/or specific filtration media may be integrated with thesupport 48.

Referring back to FIG. 1, surgical instruments can be manipulatedthrough the tear line T in clear film 38 and/or through the accessopening 32. Alternatively, the clear film 38 can be completely removed.It will be appreciated that the vacuum, and drawing effect, presented bythe plenum 28 to the surgical site may be increased by leaving the clearfilm 38 in place.

The end effector(s) 18 of the present invention may be extruded from asingle piece of material, e.g., the body 22, tubular handle 20, flexiblehose 16, and in some embodiments, a filter and connector, may be formedfrom a unitary piece of synthetic resin or similar extrudable material.The end effector(s) 18 of the present invention may be advantageouslyand hygienically disposed of after a single use, without the necessityof handling contaminated material.

In another use of the invention, the embodiments of the vacuum head 18may be used at a workstation or the like, or on or in a containmentvessel or the like, in order to remove fumes or smoke. Such workstationsand vessels may be used, for example, for cleaning components in thecomputer industry or for performing experiments or tasks in whichnoxious fumes are emitted. FIG. 20 shows such a use. The workstation 110may have hand holes 112, with or without suitable sealing collars 113 orattached gloves (not shown), through which a technician or user may puttheir gloved or ungloved hands. The vacuum head 18 may be positioned in,adjacent to or on the workstation 110, for example, as depicted, it maybe coupled to an exterior surface of the workstation enclosure adjacentto an opening in the wall defining the workstation. It may also becoupled to an interior surface. When a suction force is applied to thevacuum head 18, the vacuum head 18 receives smoke or fumes from theinside of the workstation. In one embodiment, an air supply, or supplyof ultra-clean air and/or other gases, may be pumped into theworkstation 110 through a hose 114 to help urge the vapors, aerosols orgaseous material toward the vacuum head 18. Such an air supply mayprovide air at any given rate; one such rate for a typical-sized workstation may be 30 cubic feet per minute.

One embodiment is a method for removing fumes or smoke from a workspace,where a vacuum head as described above in several different embodimentscan be used. The head substantially defines a plenum having an innerperiphery defining a generally central opening, and has a generally openfacing adjacent to the inner periphery. The plenum has a plenum supportfor preventing the plenum from collapsing when a low pressure isestablished therein. A user places the vacuum head in or around theworkspace, couples the head to a vacuum source, and actuates the vacuumsource, providing an evacuation system for fumes and smoke. Optionally,the vacuum head may also be operably coupled to a fluid source, such asultra-clean air, or an inert gas, or combinations thereof, in order tocreate a flow of the fluid into the head and across the central opening.

The present invention may be embodied in other specific forms withoutdeparting from the essential spirit or attributes thereof. The describedembodiments should be considered in all respects as illustrative, notrestrictive.

1. An evacuation apparatus for removing gaseous byproducts or noxious vapors comprising: a head substantially defining a plenum having an outer surface, said plenum having an inner periphery defining a generally central opening, said plenum having an opening in said outer surface adjacent to the inner periphery; a plenum support for preventing the plenum from collapsing when a low pressure is established therein; a fluid source nozzle adapted to guide a fluid to the head; a plurality of manifold barriers carried by said plenum, wherein said manifold barriers are solid and cover a portion of said inner periphery adjacent to said fluid source nozzle; and a vacuum nozzle adapted to guide a fluid from the head.
 2. An evacuation apparatus for removing gaseous byproducts or noxious vapors comprising: a head substantially defining a plenum having an outer surface, said plenum having an inner periphery defining a generally central opening, said plenum having an opening in said outer surface adjacent to the inner periphery; a plenum support for preventing the plenum from collapsing when a low pressure is established therein; a fluid source nozzle adapted to guide a fluid to the head; a plurality of manifold barriers carried by said plenum, wherein said manifold barriers are perforated and cover a portion of said inner periphery adjacent to said fluid source nozzle; and a vacuum nozzle adapted to guide a fluid from the head.
 3. An evacuation apparatus for removing gaseous byproducts or noxious vapors comprising: a head substantially defining a plenum having an outer surface, said plenum having an inner periphery defining a generally central opening, said plenum having an opening in said outer surface adjacent to the inner periphery; a plenum support for preventing the plenum from collapsing when a low pressure is established therein; a fluid source nozzle adapted to guide a fluid to the head; a plurality of manifold barriers carried by said plenum; a vacuum nozzle adapted to guide a fluid from the head; and at least one baffle located in said plenum between said fluid source nozzle and said central opening.
 4. An evacuation apparatus for operatively coupling to a vacuum and a fluid source for removing gaseous byproducts or noxious vapors comprising: a head substantially defining a plenum having an outer surface, said plenum constructed of a generally non-porous material and having an opening in said outer surface adjacent to an inner periphery; and a plenum support for preventing the plenum from collapsing when a low pressure is established therein, wherein said plenum has a bottom wall, wherein said bottom wall of said plenum includes an adhesive layer for adhesive attachment of said head around a surgical site, and wherein said fluid source supplies an inert gas through said head.
 5. A medical appliance adapted to operably couple to a vacuum source and an air source, the appliance comprising: a working head having a central opening for at least partially surrounding a surgical site and including at least one air inlet for coupling to the air source and at least one vacuum outlet for coupling to the vacuum source, whereby when the vacuum outlet is operably coupled to at least the vacuum source and the vacuum source is actuated, an air flow flows through the central opening and over the surgical site, said working head defining a plenum having an outer surface, said plenum having an opening in said outer surface adjacent to an inner periphery of said central opening of said plenum, at least one baffle located in said plenum between said at least one air inlet and said at least one central opening.
 6. An evacuation apparatus for operatively coupling to a vacuum and an ultra clean fluid source to remove gaseous byproducts or noxious vapors, the apparatus comprising a head defining a plenum having an outer surface, said plenum having an inner periphery having a generally central opening defining a 360 degree arc, said plenum having an opening in said outer surface adjacent to the inner periphery so that the vacuum and laminar air flow from the ultra-clean fluid source act together to evacuate gaseous material across an area defined by the 360 degree arc, said plenum having a plenum support for preventing the plenum from collapsing when a low pressure is established therein, said head operatively coupled to said fluid source with at least one nozzle, and operatively coupled to said vacuum with at least one nozzle, wherein said at least one nozzle operatively coupled to said fluid source and said at least one nozzle operatively coupled to said vacuum are generally opposed, at least one baffle located in said plenum between said nozzle operatively coupled to said fluid source and said central opening.
 7. The evacuation apparatus according to claim 6, further comprising a piece of sheet material, said evacuation apparatus operably coupled to said piece of sheet material.
 8. An evacuation apparatus for operatively coupling to a vacuum and an ultra clean fluid source to remove gaseous byproducts or noxious vapors, the apparatus comprising a head defining a plenum having an outer surface, said plenum having an inner periphery having a generally central opening defining a 360 degree arc, said plenum having an opening in said outer surface adjacent to the inner periphery so that the vacuum and laminar air flow from the ultra-clean fluid source act together to evacuate gaseous material across an area defined by the 360 degree arc, said plenum having a plenum support for preventing the plenum from collapsing when a low pressure is established therein, wherein said plenum is constructed of a generally non-porous material.
 9. The evacuation apparatus according to claim 8, wherein said plenum support is constructed of a generally porous material.
 10. The evacuation apparatus according to claim 8, wherein said fluid source supplies an inert gas through said head.
 11. A medical appliance operably coupled to a vacuum source and a clean fluid source, the appliance comprising a working head having a central opening for being positioned around a surgical site, said working head including at least one inlet for coupling to the clean fluid source and at least one outlet for connecting to the vacuum source, whereby actuation of at least the vacuum source produces a laminar flow of clean fluid through the central opening and over the surgical site, wherein an inflow of the vacuum source is greater than or equal to an outflow of the clean fluid source including any gaseous materials removed, at least one baffle located in said working head between said at least one inlet and said central opening.
 12. The medical appliance according to claim 11, wherein said working head substantially contains clean fluid flow when actuation of the vacuum source occurs.
 13. The medical appliance according to claim 11, wherein said at least one inlet and said at least one outlet are on generally opposite sides of said working head.
 14. An evacuation apparatus for operatively coupling to a vacuum and a fluid source to remove gaseous byproducts or noxious vapors, the apparatus comprising: a head substantially defining a plenum having an outer surface, said plenum having an inner periphery having a generally central opening surrounding a surgical site and through which the fluid source provides a laminar fluid flow wherein an outflow of the fluid source is less than or equal to an inflow of the vacuum, said plenum having an opening in said outer surface adjacent to the inner periphery, said plenum having a plenum support for preventing the plenum from collapsing when a low pressure is established therein, at least one inlet nozzle for operatively coupling to the fluid source; at least one outlet nozzle for operatively coupling to the vacuum, wherein said at least one inlet nozzle and said at least one outlet nozzle are generally opposed; and at least one baffle located in said plenum between said inlet nozzle and said central opening.
 15. The evacuation apparatus according to claim 14, further comprising a piece of sheet material, said evacuation apparatus operably coupled to said piece of sheet material.
 16. An evacuation apparatus for operatively coupling to a vacuum and a fluid source to remove gaseous byproducts or noxious vapors, the apparatus comprising: a head substantially defining a plenum having an outer surface, said plenum constructed of a generally non-porous material and having an inner periphery having a generally central opening surrounding a surgical site and through which the fluid source provides a laminar fluid flow wherein an outflow of the fluid source is less than or equal to an inflow of the vacuum, said plenum having an opening in said outer surface adjacent to the inner periphery; and a plenum support for preventing the plenum from collapsing when a low pressure is established therein, wherein said plenum has a bottom wall, wherein said bottom wall of said plenum includes an adhesive layer for adhesive attachment of said head around a surgical site.
 17. The evacuation apparatus according to claim 16, wherein said plenum support is constructed of a generally porous material.
 18. The evacuation apparatus according to claim 16, wherein said fluid source supplies an inert gas through said head. 